GC-MS METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF GENOTOXIC TOSYLATES IN TENELIGLIPTIN

In this study, a specific and robust Gas Chromatography-Mass Spectrometry (GC-MS) method was meticulously developed, optimized, and validated for the precise determination of the genotoxic tosylate impurities in Teneligliptin. The method was optimized on an Agilent 5977B GC/MSD system equipped with a capillary column (HP-5MS, 30 m × 0.32 mm x 1.0 μm) using helium as the carrier gas. Detection of the impurities was achieved using selective ion monitoring mode at specific mass-to-charge ratios. The method excelled in validation for various parameters, including specificity, sensitivity, precision, linearity, accuracy, selectivity, and robustness. It demonstrated linear behavior in the concentration range of 0.54, 0.55, and 0.53 to 3.0 ppm with high correlation coefficients. The detection and quantitation limits of genotoxic tosylates for Teneligliptin were also determined.